Buhe 1984.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 18% drop out after 3 years (study duration = 3 years). No differential group losses. | |
Participants | 1286 children analysed at 3 years (available at final examination). Age range at start: 11‐13 years (average = 12). Surfaces affected at start: 17.4 DMFS. Background exposure to fluoride: data not obtained for fluoridation status of site. Year study began: 1976. Location: FRG. | |
Interventions | FT (2 groups) versus PL
(SMFP groups = 1000 ppm F and 1500 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: IMP. |
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Outcomes | 3yNetDFS increment ‐ cl+xr.
Reported at 3 years follow up. DMFS. DMFS (U). DMFT. |
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Notes | Participants randomised (N = 1562). Baseline characteristics (age, TAR, DMFS) 'balanced' (DFS baseline data NR). Clinical (VT) caries assessment; diagnostic threshold NR; state of tooth eruption included E/U. Radiographic caries assessment; diagnostic threshold NR. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |